Breast Cancer Clinical Trial
— PROSPECTSOfficial title:
Prospective Randomized Trial of Digital Breast Tomosynthesis (DBT) Plus Standard 2D Digital Mammography (2DDM) or Synthetic 2D Digital Mammography (S2D) Compared to Standard 2DDM in Breast Cancer Screening.
NCT number | NCT03733106 |
Other study ID # | 199080 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | December 17, 2018 |
Est. completion date | July 2024 |
The accuracy of standard two dimension digital mammography (2DDM) in breast cancer screening
is limited because of superimposition of normal breast structures onto a two dimensional
image. Mammography signs of breast cancer may be obscured, resulting in delay in the
diagnosis of breast cancer. Conversely, superimposition of normal tissues may produce
features on mammography which are suspicious for cancer and lead to recall for further tests.
Digital breast tomosynthesis (DBT) is a new x ray mammography technique which provides three
dimensional information to the film reader, overcoming many of the interpretation problems
due to tissue superimposition. Studies of DBT + 2DDM in screening have shown increased cancer
detection rates and lower false positive recall rates. There may be increased costs related
to the technology and reading times.
The aim of this study is to measure the impact and cost effectiveness of DBT + 2DDM in
routine screening compared to standard 2DDM.100,000 women wil be recruited using NHS BSP
screening sites. At each site, through a clinic randomization process, half of the
participants will undergo standard screening with 2DDM (the control group) and half will
undergo screening using DBT+2DDM.
Status | Recruiting |
Enrollment | 100000 |
Est. completion date | July 2024 |
Est. primary completion date | July 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 50 Years to 70 Years |
Eligibility |
Inclusion Criteria: - women aged 50-70 years attending for routine breast cancer screening Exclusion Criteria: - women aged 47-49 and 71-73 invited to participate in the age extension trial - women who are unable to give informed consent |
Country | Name | City | State |
---|---|---|---|
United Kingdom | King's College Hospital NHS Foundation Trust | London |
Lead Sponsor | Collaborator |
---|---|
King's College Hospital NHS Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To compare the cost effectiveness of breast cancer screening with digital breast tomosynthesis and 2DDM vs standard screening with 2DDM | To compare the effectiveness of breast cancer screening with DBT and 2D mammography with standard 2D mammography screening by measuring the internal cancer rate in women undergoing DBT and 2D mammography VS the interval cancer rate in women undergoing standard 2D mammography. (Estimated interval cancer rates - intervention group 1.85/1000 screened; control group 2.85/1000 screened) |
outcome measures to be reported from 2-7 years following beginning of recruitment into the trial |
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